FDA Grants IDE, Approving Human Study With Hemopurifier
After a years-long quest, Aethlon Medical (OTC BB:AEMD) cleared what we view as a major milestone, announcing this morning that they received IDE approval to initiate a human feasibility study with Hemopurifier. Whether FDA would approve an IDE was an ongoing question in our mind and, given that such an approval would be required as a first step towards potential U.S. commercialization (where we believe the bulk of potential opportunity lies) of the device, was something that could have been highly detrimental to AEMD had FDA denied the IDE request.
As a reminder, in early January 2013 AEMD announced that they submitted an IDE to the FDA seeking approval to commence a 10-patient safety and effectiveness feasibility study of Hemopurifier. Included in the submission was data from the recent and ongoing studies at hospitals in India as well as HCV capture data, the latter which that the FDA had requested at a pre-IDE meeting in 2011. Then in late-March, following response from FDA which included comments and study design considerations, AEMD resubmitted the IDE.
FDA subsequently communicated that they were withholding clearance of the IDE until AEMD addressed the agency's safety concern, namely that the company detail their training and monitoring procedures for heparinization - the anticoagulant used during dialysis and with the Hemopurifier. AEMD noted in early May that they were gathering the requested information and expected to have it submitted to FDA in the coming week (i.e. - by mid-May). Given this morning's news of the approved IDE, FDA's safety concerns have clearly been satisfied.
The feasibility study will enroll 10 end stage renal disease patients infected with HCV to demonstrate safety of Hemopurifier therapy. The patients, which must not have received any HCV drug therapy for at least the preceding 30 days, will receive three treatments of standard dialysis in the first week (i.e. - control phase),
followed by a total of six dialysis treatments using Hemopurifier over the next two weeks. The rate of adverse events during the control and Hemopurifier treatments will be compared. Viral load changes will also be measured in order to provide an indication of efficacy. AEMD also notes that they may also collect HCV capture data (another efficacy metric with positive results in trials in India and which FDA had previously indicated interest in). AEMD had previously announced that the study is expected to be conducted by the Renal Research Institute, a partnership between Fresenius Medical Care (FMS), a leader in dialysis products and services, and Beth Israel Medical Center in NYC. AEMD is now in the process of preparing for the study.
Assuming positive results, the expectation is this will lead to larger U.S. studies to support an eventual FDA approval filing. And while we do not expect U.S. commercialization to be a near-term event, IDE approval to conduct human studies is a huge positive, meaningful hurdle that's now cleared and significantly increases the likelihood of initiation of larger studies to support an eventual FDA filing.